Clinical Trials

MainTitle

GSK1265744 (Cabotegravir, CAB) for Named Patient/Compassionate Use in HIV

This study has been available
Sponsor
ViiV Healthcare


Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT03462810

First received: March 5, 2018
Last updated: March 5, 2018
Last Verified: March 2018
History of Changes
Purpose

Purpose

The goal of this compassionate use program is to provide a mechanism to supply Cabotegravir, CAB on an individual named patient basis for treatment of individuals who have no available treatment alternatives and/or limited treatment options (e.g., who are unable to participate in the Phase III clinical studies or do not qualify), and are in need of new drugs to construct an effective antiviral regimen and may require the use of parenterally administered drug given underlying medical conditions. You can access ViiV's Policy on Compassionate via https://us.viivhealthcare.com/media/124424/viivs-external-policy-on-cup_final-version_23feb20 17.pdf.

Condition Intervention
Infection, Human Immunodeficiency Virus

Drug : cabotegravir, CAB

Study Type: Expanded Access   What is Expanded Access?
Official Title: GSK1265744 (Cabotegravir, CAB) for Named Patient/Compassionate Use in HIV

Further study details as provided by ViiV Healthcare:

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  

Criteria

Inclusion Criteria:

  • HIV-infected patients will be eligible for treatment if ALL the following apply:
    • Male or female patients aged ≥ 18 yrs

    • NOTE: all female patients of reproductive potential should use every precaution to prevent pregnancy including either complete abstinence from intercourse from 2 weeks prior to administration of CAB, throughout receipt of CAB and for at least 52 weeks after discontinuation of CAB LA; or use of one of the following methods of highly reliable contraception:
  • Contraceptive subdermal implant
  • Intrauterine device or intrauterine system
  • Combined estrogen and progestogen oral contraceptive
  • Injectable progestogen
  • Contraceptive vaginal ring
  • Percutaneous contraceptive patches
  • Male partner sterilisation with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. The documentation on male sterility can come from the site personnel's: review of subject's medical records, medical examination and/or semen analysis, or medical history interview provided by her or her partner.

  • These allowed methods of contraception are only effective when used consistently/correctly and in accordance with the product label. The investigator is responsible for ensuring that patients understand how to properly use these methods of contraception.
    • Inability to construct a viable antiviral treatment regimen with commercially available medications;
    • Demonstrated need for a long acting, injectable antiretroviral including, but not limited to malabsorption or inability to achieve adequate drug levels via oral route. NOTE: Poor/incomplete adherence to oral meds is not a sufficient rationale for inclusion.
    • The patient/legal guardian or representative has given informed consent to treatment prior to administering CAB (in a manner consistent with all national requirements). The patient/legal guardian or representative has also given informed consent for the transmission of a copy of the anonymized adverse and serious adverse event (SAE) and pregnancy reports (in compliance with local regulatory authority requirements) to GSK and ViiV where allowable by local regulations, and to the country regulatory authority as required.

    • Exclusion Criteria:
    • Patients will not be eligible for treatment if ANY of the following apply:
      • Patient has estimated creatinine clearance <50 mL/min via Cockcroft-Gault method;
      • Females who are pregnant or women who are breastfeeding, or plan to become pregnant or breastfeed during treatment.
      • Patients who have had known or suspected allergic reaction or hypersensitivity reactions to integrase inhibitors;
      • Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN)
      • ALT ≥ 3 times ULN and bilirubin ≥ 1.5 times ULN (with > 35% direct bilirubin)
      • Evidence for moderate to severe hepatic impairment, grade 3-4 liver fibrosis, or cirrhosis
      • Patients who are eligible for actively enrolling clinical trials involving CAB.
      • Significant coagulopathy precluding chronic IM dosing
      NOTE: Patients should not be treated via the named patient/compassionate use program if they are eligible and/or able to participate in any of the Phase III clinical trials of CAB and the patient is suitable for participation in such clinical trials. In that instance (assuming consent is obtained) the patient should preferentially be enrolled into the ongoing clinical trial to allow detailed data collection. In accordance with national requirements patients should not be treated in the named patient/compassionate use program if they have responded to previous treatment with CAB in another clinical trial without review and prior approval by the VSLC.

      contacts and locations

      Contacts and Locations

      Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

      Please refer to this study by its ClinicalTrials.gov identifier: NCT03462810

      Contacts

      Contact:   US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

      Locations

      United States, California
      GSK Investigational Site
      San Francisco, California, United States, 94115
      Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
      Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
      United States, Georgia
      GSK Investigational Site
      Atlanta, Georgia, United States, 30322
      Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
      Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
      United States, North Carolina
      GSK Investigational Site
      Durham, North Carolina, United States, 27710
      Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
      Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
      United States, Texas
      GSK Investigational Site
      Bellaire, Texas, United States, 77401
      Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
      Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
      Canada
      GSK Investigational Site
      Edmonton, Alberta, Canada, T5H 3V9
      Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
      Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
      France
      GSK Investigational Site
      Colombes, France, 92700
      Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
      Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
      Portugal
      GSK Investigational Site
      Setúbal, Portugal, 2910-446
      Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
      Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
      Switzerland
      GSK Investigational Site
      Zurich, Switzerland, CH-8063
      Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
      Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
      United Kingdom
      GSK Investigational Site
      Tooting, London, United Kingdom, SW17 0QT
      Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
      Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com

      Sponsors and Collaborators

      ViiV Healthcare

      Investigators

      Study Director: GSK Clinical Trials ViiV Healthcare
      More Information

      More Information


      Responsible Party: ViiV Healthcare  
      ClinicalTrials.gov Identifier: NCT03462810   History of Changes  
      Other Study ID Numbers: 205741  
      Study First Received: March 5, 2018  
      Last Updated: March 5, 2018  

      Keywords provided by ViiV Healthcare:

      cabotegravir, CAB
      GSK1265744
      Individual Patient Compassionate Use
      HIV

      Additional relevant MeSH terms:
      Acquired Immunodeficiency Syndrome
      HIV Infections

      ClinicalTrials.gov processed this data on October 15, 2019
      This information is provided by ClinicalTrials.gov.